RE: High confidence of FDA approval. Approval = about 3.00p a share?20 Jan 2026 19:21
Application was submitted in August. FDA then issued a clarification request in mid November. Once Nuformix responded, the file would have been back with the FDA as a complete application again.
From that point, the standard FDA target is around 90 days to issue a decision.
If the clarification response went in around the same time as the November RNS, then 90 days takes us to around 10 February 2026.
We are now already deep into that timeframe.
So realistically:
• This should already be close to resolution.
• We are firmly in the decision window now.
• If granted, it can show up on the FDA orphan database before any RNS.
On that basis, I’d personally be surprised if this isn’t resolved within the next couple of weeks, unless there’s been another FDA query we’re not aware of.
So… maybe tomorrow